One MORE for Chronic Pain in Latinos

NCT ID: NCT06316713

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually either in-person or via a HIPAA compliant virtual meeting platform.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

One MORE (Spanish Adaptation)

Group Type EXPERIMENTAL

One MORE (Spanish Adaptation)

Intervention Type BEHAVIORAL

One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into two, 1-hour segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Participants will also be guided through a mindful pain management practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The second segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, as well as learning to focus on increasing the positive emotions that can attenuate pain with mindful savoring.

Waitlist Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

One MORE (Spanish Adaptation)

One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into two, 1-hour segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Participants will also be guided through a mindful pain management practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The second segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, as well as learning to focus on increasing the positive emotions that can attenuate pain with mindful savoring.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Spanish-speaking
* Age 18+
* Diagnosed with a chronic pain condition
* Average pain in the previous week \> or = 3
* Willingness to participate in study interventions and assessments.

Exclusion Criteria

* Non Spanish-speaking
* Score of 10 or greater ('high risk') on the suicidality subsection of the MINI
* Psychotic episode within the last 12 months as deemed by the corresponding subsection of the MINI
* Presence of clinically unstable illness judged to interfere with treatment or study procedures
* Unable or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
* Communication or cognitive impairment that limits participation in treatment or study procedures.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Utah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eric Garland

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eric Garland, PhD

Role: CONTACT

801-581-3826

Carter Minnick, BA

Role: CONTACT

804-912-6338

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eric Garland, PhD

Role: primary

801-581-3826

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB_00166637

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Conversion to Embeda With Rescue Trial
NCT01179191 TERMINATED PHASE4